BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12422371 · Received September 3, 2021

    Report

    Report Number
    3013756811-2021-96052
    Event Type
    Injury
    Date Received
    September 3, 2021
    Date of Event
    August 16, 2021
    Report Date
    September 3, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL OF 19-20 MG/DL. REPORTEDLY, THE SUSPECTED CAUSE OF BG WAS THAT THE CUSTOMER WAS SICK WITH THE FLU. THE CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM WAS IN THE MIDDLE OF A ROUTINE 2 HOUR WARMUP PERIOD SO CUSTOMER WAS NOT ACTIVELY RECEIVING CGM READINGS, AND THEREFORE THE CONTROL-IQ TECHNOLOGY WAS NOT ACTIVE AT THE TIME OF THE EVENT. CUSTOMER REQUIRED ASSISTANCE TO RESOLVE BG. THEY HAD SUPPER, WERE GIVEN CHERRY-FLAVORED GLUCOSE TOOTHPASTE, GLUCO-GEL, AND TAKEN TO THE EMERGENCY ROOM (ER). AT THE ER, CUSTOMER WAS TREATED WITH D-50, IV DRIP WITH GLUCOSE, AND INSULIN BY INJECTION. CUSTOMER WAS RELEASED FROM FROM ER AFTER 13 HOURS WITH NO PERMANENT DAMAGE. ISSUE HAD OCCURRED IN THE PAST AND THEREFORE NO PUMP TROUBLESHOOTING COULD BE PERFORMED. CUSTOMER TECHNICAL SUPPORT PERFORMED A PUMP SYSTEM CHECK AND CONFIRMED PUMP IS FUNCTIONING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320198 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention INSULIN: NOVOLOG